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The HEARTFELT Study
NCT06222099 · View on ClinicalTrials.gov ↗
Study Summary
This pragmatic randomized crossover trial looks at the effect(s) of using a remote patient monitoring device (Heartfelt device) with health alerts to monitor the development of peripheral edema in patients with heart failure (HF). The hypothesis is that this passive measurement method will lead to better data availability, which in turn will improve patient care and reduce hospitalizations for the management of worsening HF (HF hospitalizations, HFHs) in nonadherent participants with chronic HF. The study objectives are: * Primary objective: Establish if the Heartfelt device is safe to use and effective at reducing HFHs. * Secondary objectives: 1. Establish the effect of the Heartfelt device on data availability compared to existing remote monitoring devices. 2. Establish the effect of the Heartfelt device on HF clinical outcomes. Participants will need to: * Install the device in their home for at least a year and up to 4 additional years after. * Reply to remote patient monitoring phone calls to follow the care plans.
Conditions Studied
Interventions
- OTHER Questionnaires
- OTHER Standard care
- DEVICE Heartfelt Device installed
- DEVICE Heartfelt-guided care
Study Locations (3)
Georgia
- Rimidi — Atlanta
New Jersey
- HealthArc — Hackensack
Pennsylvania
- Connect America — Bala-Cynwyd
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2025-10-23 |
| Est. Completion | 2030-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06222099
The ClinicalTrials.gov registry entry for NCT06222099 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Heartfelt Technologies, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 4 interventions — of which Questionnaires is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06222099 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Georgia, New Jersey, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06222099 about?
NCT06222099 is a clinical study titled "The HEARTFELT Study". This pragmatic randomized crossover trial looks at the effect(s) of using a remote patient monitoring device (Heartfelt device) with health alerts to monitor the development of peripheral edema in patients with heart failure (HF). The hypothesis is that this passive measurement method will lead to b...
What is the current status of trial NCT06222099?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,500 participants. The study started on 2025-10-23. Estimated completion is 2030-12-31.
What conditions does trial NCT06222099 study?
This clinical trial studies the following conditions: Heart Failure, Chronic Heart Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06222099?
The interventions under investigation include: Questionnaires (OTHER), Standard care (OTHER), Heartfelt Device installed (DEVICE), Heartfelt-guided care (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06222099?
This trial is sponsored by Heartfelt Technologies, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06222099 being conducted?
This trial has 3 study locations across Georgia, New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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